It has been widely recognized that methods and systems for insuring proper medication ingestion or administration by individuals are very important in defending against unnecessary sickness, deaths and other problems. Giving instructions and then letting patients fend for themselves has been shown not to work particularly well. This is because it is not only the improper ingestion of medicines that is the primary cause of medical danger. Rather, an overall lack of sufficient patient guidance is also part of the problem. As has been shown in regards to various public health medication administration situations, such as administration of tuberculosis medication by the WHO, Directly Observed Treatment (DOT) improves compliance of patients. Global Tuberculosis Control: A Short Update to the 2009 Report, World Health Organization, 2009. As is shown in this report, funding for implementing DOT programs is high. Thus, the ability to implement such a program with less of a financial burden would be desirable.
The total healthcare cost of drug-related morbidity, including poor adherence, is estimated at $290 billion per year in the US. Treatment of patients with poor adherence can require twice the resources from the healthcare system than treatment of more compliant individuals. Mortality and morbidity rates are much higher for patients who do not follow their prescribed drug therapy, especially for patients suffering from a chronic illness. Currently, 75% of healthcare spending in the US is directed towards treatment of chronic disease. These same chronically ill patients who are also non-adherent to their medication prescriptions are twice as likely to be hospitalized. Low levels of medication adherence also contribute to the high costs of clinical trials. In the US, patient recruitment is estimated at $6533 per individual and up to three times that amount to replace someone who has left. As a result, the number of clinical trials conducted abroad has been increasing. By 2012, an estimated 65% of FDA-regulated clinical trials will be conducted outside of the US, raising issues around regulation and supervision.
Dr Lars Osterberg, M.D. and Dr, Terence Blaschke have reported in the New England Journal of Medicine, Adherence to Medication, (N Engl J Med 2005; 353:487-97) 2005 an alarming lack of adherence to required medication protocol, further noting that while the average rates of adherence in clinical trials is categorized as “high”, this number still comprises only rates of 43 to 78 percent. Most importantly, the authors note “The ability of physicians to recognize nonadherence is poor, and interventions to improve adherence have had mixed results.” Adherence, p. 487. The authors conclude “Poor adherence to medication regimens is common, contributing to substantial worsening of disease, death and increased healthcare costs.” Adherence, p. 494. The Trend Repot Series, 2008 Patient Adherence Update: New Approaches for Success, October 2008, report similar discouraging statistics. This broad range may possibly contribute to the public confidence in the FDA approval process and the importance of continued surveillance of a drug throughout the process. Furthermore, it may help to explain why, according to the Journal of the American Medical Association (JAMA May 1, 2002), one out of every five new drugs that comes to market in the US is found to have serious or life-threatening adverse effects—unknown or undisclosed at the time of approval. Similar failure to adhere to medication prescriptions plagues the population health management field. It is against this backdrop of poor adherence, and potential danger to patients, that the present invention operates.
Traditional monitoring methods have problems with reliability and cost, and may place a substantial burden on the patient. Pill counting and patient interviews are unreliable ways of measuring medication adherence, as is evidenced in the above studies, as they offer no information on the time of day medication is taken or whether the patient has skipped doses entirely. Self-reporting by individuals, even employing ePRO diaries, IVRS or web portal communications have also been shown to be untrustworthy as many patients fail to record accurate data. Technologically advanced solutions, such as digital pill container caps and smart packaging report only when the patient has opened the medication container and cannot confirm medication administration. Smart pills, while accurate, are expensive, require a modification to the manufacturing process, and are inconvenient for the patient. Even if patients are not intentionally deceptive, barriers to medication adherence such as the perceived impact of a medicine, knowledge about illness, forgetfulness, or lack of social support, are contributing factors to why 75% of Americans do not take their medicine as prescribed.
An extremely effective way to confirm medication adherence is through direct observation. The WHO's Directly Observed Treatment, short course (DOTs) program has radically improved overall compliance rates of TB patients. Indeed, such direct observation is typically employed in phase 1 clinical trials, where assurance of adherence is critical. Unfortunately, the labor-intensive nature of the program—hiring care workers to directly monitor patients—is expensive, and places a substantial burden on the patient. [AI Cure Technologies will provide an automated virtual direct observation solution, AiView™ that may be applied to larger populations for a fraction of the cost of DOTs. AiView™ will leverage the increasing familiarity and access to webcam-enabled devices by incorporating a gesture and object recognition monitoring platform.] Traditionally, participants attend introductions and follow ups for clinical trials, or in other disease management situations, in-person. Once the initial start up has been performed, however, patients are typically on their own to confirm that they are properly taking their medication. Infrequent checkups, typically every few weeks or longer, have proven to be insufficient. A number of systems exist that provide instructions to a user regarding when to take a medication and records when the user indicates that a medication has been taken. U.S. Pat. No. 7,359,214 describes such a system. A device is provided that provides instruction to a patient regarding medications to take. Furthermore, the system may provide a method for determining that the prescription is appropriate given the patient's conditions, and other medications he or she may already be taking. The system may monitor the dispensing of medicine in accordance with a predetermined treatment protocol. While such a system provides many improvements for easing a burden on the patient, this system suffers in many ways
U.S. patent application Ser. No. 11/839,723, filed Aug. 16, 2007, titled Mobile Wireless Medication Management System provides a medication management system employing mobile devices and an imaging technology so that a user is able to show a pill to be taken to the system, and the system can then identify the medication. Patient histories are available to an administrator, including various vital signs as measured by the system. Images may also be taken of the patient, provider, medication container or the like. While the system professes to ensure adherence to a protocol, the system only provides such help if requested by a user. There is in fact no particular manner in which to ensure actual adherence or ingestion of the medication, or the relationship of adherence to the efficacy or safety of the drug over time. When requiring adherence to a predetermined protocol for a clinical trial, this is particularly relevant. Similarly, there is no mention of non-pill based medications. Furthermore, there is an assumption that a medication has been already trained to be recognized by the system, an assumption that may cause a problem given the number of different possible medications, including generic medications, that may be taken by an individual in accordance with a particular prescription.
Therefore, it would be desirable to provide an apparatus that overcomes the drawbacks of the prior art.